Qorvo® announced last week that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization for the Qorvo Omnia™ SARS-CoV-2 Antigen Test. The test is authorized for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19.
At the same time, the company announced it was awarded a $24.4 million contract with the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics initiative. The contract, awarded to Qorvo Biotechnologies, a wholly owned subsidiary of Qorvo, helps advance the production and market launch of the Qorvo Omnia™ diagnostic test platform.
According to Qorvo, the Omnia platform represents a paradigm shift in diagnostic testing capability by using BAW sensors to achieve SARS-CoV-2 (COVID-19) antigen testing in approximately 20 minutes. BAW sensor technology enables low Limit of Detection levels that are similar to molecular testing capability.
When fluid flows over the piezoelectric surface, analytes of interest bind to the target molecules increasing the mass on the surface which causes a shift in the BAW frequency that can be translated into a known concentration. Because it is oscillating at 3 GHz, it has high sensitivity making it a reliable and accurate test.
The Qorvo Omnia platform features a portable test instrument, microfluidic cartridge and secure connectivity. The microfluidic cartridge design enables specific binding with additional wash steps similar to central lab instrument operation and demonstrated results including 100% specificity during clinical trials.
BAW enables surface-based mass measurement using high frequency and surface binding. BAW allows for multiplexing (multiple analytes from a single sample) and the test cartridge is designed to measure across multiple sample matrices such as whole blood, serum, plasma, saliva and more. The goal is to enable clinicians' access to test data in minutes.
Here are the steps:
Qorvo Biotechnologies brings a unique approach to the health diagnostics testing landscape by leveraging the power of BAW RF technology—a proven technology currently used in numerous products cellular infrastructure and mobile phones.
- With BAW RF technology, sensitivity (Limit of Detection) increases with frequency
- Qorvo’s BAW resonates at 3 GHz frequency
- Sensitivity scales with the square of the frequency, making certain assays capable of 1 pg/mL LOD with BAW
- Changes in mass from surface binding are easily measured through RF detection
- Fundamental technology enables millions of mobile phones worldwide — repurposed as a high sensitivity sensor for use in biotechnology applications
Test Cartridge and Reagent Carousel:
- Low-cost injection molded cartridge body contains the BAW sensor and a pipette tip
- The foil-sealed reagent carousel contains reagents and wash buffers to reduce non-specific binding—the cartridge/carousel acts as a portable laboratory chemistry bench
- The Omnia instrument actuates the carousel motion during the test process
The Omnia™ Platform Features:
- A small instrument measuring 10” x 9” x 5”
- Menu-driven touchscreen provides instructions for every step of the test procedure
- On-screen test results can be printed or uploaded by Ethernet, Cellular or Wi-Fi connections
It will be very interesting to see what other tests are implemented on this platform and if they test time can be further reduced. This system can be used with many different fluids so could see a wide variety of tests being done on the small, fast platform allowing small doctors offices and vets to utilize on the spot testing for their patients with results in minutes.